UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019836 |
|---|---|
| Receipt number | R000022884 |
| Scientific Title | The efficacy of pulsed radiofrequency for lumbosacral radicular pain a comparison of varying pulsed radiofrequency times |
| Date of disclosure of the study information | 2015/11/20 |
| Last modified on | 2017/11/19 16:45:09 |
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Basic information
Public title
The efficacy of pulsed radiofrequency for lumbosacral radicular pain a comparison of varying pulsed radiofrequency times
Acronym
The efficacy of pulsed radiofrequency for lumbosacral radicular pain a comparison of varying pulsed radiofrequency times
Scientific Title
The efficacy of pulsed radiofrequency for lumbosacral radicular pain a comparison of varying pulsed radiofrequency times
Scientific Title:Acronym
The efficacy of pulsed radiofrequency for lumbosacral radicular pain a comparison of varying pulsed radiofrequency times
Region
| Japan |
Condition
Condition
lumbosacral radicular pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the optimum pulsed radiofrequency times for lumbosacral radicular pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual analogue scale (VAS) is assessed immediately before, and immediately, 1 hour, 2hours, 1 day, 1 week, 1 month, 3 months, 6 months, 1 year after pulsed radiofrequency
Key secondary outcomes
the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOA BPEQ) is assessed immediately before, and 1 week, 1 month, 3 months, 6 months, 1 year after pulsed radiofrequency
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
pulsed radiofrequency for 3 minutes
Interventions/Control_2
pulsed radiofrequency for 5 inutes
Interventions/Control_3
pulsed radiofrequency for 10 minutes
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
lumbosacral radicular pain caused by lumbar degenerative disease
Key exclusion criteria
can not be self-assessment of pain
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Fujii |
Organization
Kajiki Hospital
Division name
Anesthesiology
Zip code
Address
1231-1 Nishihanajiri Kita-ku, Okayama
TEL
086-293-3355
hiromif@ktd.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Fujiii |
Organization
Kajiki Hospital
Division name
Anesthesiology
Zip code
Address
1231-1 Nishihanajiri Kita-ku, Okayama
TEL
086-293-3355
Homepage URL
hiromif@ktd.biglobe.ne.jp
Sponsor or person
Institute
Kajiki Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
梶木病院（岡山県） Kajiki Hospital (Okayama prefecture)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2017 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022884
